Regulatory and Monetary Drivers for Real-Time Analytics

by Barry Rosenblatt, PhD
Volume 15, Issue 1 (Spring 2016)

Implementation of “real-time” analytics (RTA) in processes for biologics is challenging from a technological and timeline perspective. Therefore, there need to be significant drivers from both a regulatory (quality) and a monetary standpoint to justify investment. Understanding how regulatory agencies define real-time analytics and the expectations for implementations (how and when) is a key component to rational decision-making, and dovetailing process improvement and facility design is important in the planning and development process...

Rosenblatt B. Regulatory and monetary drivers for real-time analytics. BioProcess J, 2016; 15(1): 5–9.

Posted online April 7, 2016.